]>
IRCT20250904067125N1 IRCT 2025-09-14 Zahedan University of Medical Sciences Comparison of the Effect of Oral versus Sublingual Vitamin D3 Supplementation on Serum 25-Hydroxyvitamin D Levels in Medical Students with Vitamin D Deficiency: A Randomized Clinical Trial Comparison of serum levels of 25-hydrovitamin D after taking oral or sublingual vitamin D in medical students with insufficient serum vitamin D 2025-10-21 anticipated 60 Complete https://irct.ir/trial/86000 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible participants who meet the inclusion criteria will be randomly assigned to one of the two intervention groups using a blocked randomization method, generated by random number software. The allocation sequence will be prepared by an independent colleague not involved in the screening or intervention process and will be concealed in sequentially numbered, opaque, sealed envelopes. The principal investigator will open the corresponding envelope only after confirming the participant's eligibility and assigning them a study ID, thereby revealing the assigned intervention (oral or sublingual supplement). This procedure ensures that both the participants and the investigating researcher are blinded to the group assignment during the allocation process, Blinding description: Based on whether the patient's visit invoice number is even or odd, the patient is assigned to either group A or B, and one of the two formulations (oral or sublingual) at a dose of 50,000 units is administered by the clinical caregiver. The patient has no information about the treatments received by others. The researcher, outcome assessor, and data analyst are only aware of the findings from groups A and B and have no knowledge of which drug formulation was administered in each group. 3 Vitamin D deficiency. Intervention 1: Intervention Group 1: Patients in this group will receive one 50,000 IU vitamin D pearl (D-Vitin; manufactured by Zahravi Pharmaceutical Company) weekly for 8 weeks. Serum vitamin D levels will be remeasured at the end of the eighth week. Intervention 2: Intervention Group 2: Patients in this group will receive a sublingual form of vitamin D at a dose of 50,000 IU (manufactured by Zahravi Pharmaceutical Company). Serum vitamin D levels will be measured again at the end of the eighth week after treatment. Yes - There is a plan to make this available What will be shared: Only the portion of data relevant to the main topic is displayed. When: Access period begins 6 months after the publication of results. To whom: Will only be accessible to researchers affiliated with academic and scientific institutions. Conditions: There are no special requirements Where to obtain: Please refer to Dr. Mahperi Zafar Zaman, Internal Medicine Department, Imam Ali Ibn Abi Talib Hospital, Zahedan. How to obtain: Requests will be reviewed via email at dr.zafarzaman@zaums.ac.ir and responded to in the shortest possible time Comments:
public Mahpari Zafar Zamen
Medical Sciences Campus, Zahedan University of Medical Sciences, Persian Gulf Boulevard, Zahedan, Iran
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5770 Dr.zafarzamen@zaums.ac.ir Zahedan University of Medical Sciences scientific Mahpari Zafar Zamen
Medical Sciences Campus, Zahedan University of Medical Sciences, Dr. Hessaby Square, Zahedan, Iran.
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5570 Dr.zafarzamen@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Being a medical student at Zahedan University of Medical Sciences. Aged between 18 and 30 years. Diagnosed with vitamin D deficiency, defined as a serum 25-hydroxyvitamin D level below 20 ng/mL. Willingness to participate and provision of signed informed consent. Not having taken any vitamin D or calcium supplements within the 3 months prior to the start of the study. 18 years 30 years Male Presence of chronic diseases affecting vitamin D or calcium metabolism (e.g., renal or hepatic failure, hyperparathyroidism, sarcoidosis). Presence of malabsorption syndromes (e.g., celiac disease, Crohn's disease, ulcerative colitis). Use of medications known to interfere with vitamin D metabolism (e.g., anticonvulsants, systemic glucocorticoids, azole antifungals). History of hypercalcemia or calcium kidney stones. Pregnancy or lactation. Known hypersensitivity to vitamin D or any excipients in the study tablets. Unwillingness to continue cooperation or concurrent participation in another clinical trial. E55 Vitamin D deficiency Treatment - Drugs Treatment - Drugs Intervention Group 1: Patients in this group will receive one 50,000 IU vitamin D pearl (D-Vitin; manufactured by Zahravi Pharmaceutical Company) weekly for 8 weeks. Serum vitamin D levels will be remeasured at the end of the eighth week. Intervention Group 2: Patients in this group will receive a sublingual form of vitamin D at a dose of 50,000 IU (manufactured by Zahravi Pharmaceutical Company). Serum vitamin D levels will be measured again at the end of the eighth week after treatment. Serum vitamin D level. Timepoint: Measurement of serum vitamin D levels at baseline and at the end of the eighth week. Method of measurement: Based on the measurement of serum 25-hydroxyvitamin D levels in the laboratory. Serum vitamin D level. Timepoint: Measurement of serum vitamin D levels at baseline and at the end of the eighth week. Method of measurement: Based on the measurement of serum 25-hydroxyvitamin D levels in the laboratory. Zahedan University of Medical Sciences Approved 2024-10-12 Ethics Committee of Zahedan University of Medical Sciences Medical Sciences Campus,Dr. Hessaby Square Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)